PREMIUM HAND SANITIZER GEL- alcohol gel

PREMIUM HAND SANITIZER Gel by

Drug Labeling and Warnings

PREMIUM HAND SANITIZER Gel by is a Otc medication manufactured, distributed, or labeled by Ester Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: ALCOHOL 70%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Carbomer, Triethanolamine, Fragrance, Aloe Arborescens Leaf Extract, polysorbate 20

PURPOSE

Purpose: ANTISEPTIC

WARNINGS

Warnings:

Flammable, Keep away from fire or flame

For external use only

When using this product do not use in or near the eyes.
In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep our of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Uses

Uses:

For handwashing when water is not available to decrease bacteria on the skin
- After changing diapers
-  After assisting ill persons
-  Before contact with a person under medical care or treatment
-  Recommended for repeated use

Directions

Directions:

-  Apply palmful to hands
-  Rub hands together vigorously until dry
-  Supervise children in the use of this product

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PREMIUM HAND SANITIZER GEL 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74004-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	350 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74004-001-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/08/2020

Labeler - Ester Co., Ltd. (688425766)

Registrant - Ester Co., Ltd. (688425766)

Establishment
Name	Address	ID/FEI	Business Operations
Ester Co., Ltd.		688425766	manufacture(74004-001)